Never ever a 483?
We can not promise that you will never get a 483
but we know that the GMP MANUAL includes all
procedures and processes you need to be
GMP compliant.
Newsletter registration
PDA Parenterals Conference
From 26-28 October, 2010 the PDA Parenterals Conference will be held in Berlin.
This outstanding event will cover the very important topics:
- Future of Parenterals
- Packaging and Impact on Quality
- Manufacturing Flexibility and Control
- Innovative Plants
- Monitoring Technologies
- Medical and Application Devices
- Regulatory Trends
Don´t miss this interesting conference in Berlin, Germany.
News about GMP/cGMP
FDA´s Sharfstein Outlines Principles
The four principles of the agency are:
- Prevention
- Usage of best available science
- Transparency
- Premise of public health
Sharfstein also brought up the quality trio guidelines finalized by the International Conference on Harmonization, ICH Q8, Q9, and Q10, as an example of how industry can prevent problems. “The goal of these efforts is to understand from the start what makes a product of high quality rather than waiting to discover a problem after the fact,” he said. “[FDA] would like to foster more such productive collaboration that leads to concrete results in preventing problems.” (Source: PharmTech.com)
The mindset of the FDA changed in the point of international collaboration in the last time. At the conference we heard from different FDA managers that the cooperation with EMEA and other agencies are getting better and better. In consideration of the upcoming key issues (global supply chain, counterfeiting, global diseases, ...) is an international cooperation necessary more than ever.